CAPACorrectiveandprevention

1. Annual Review– An evaluation, conducted at least annually, that assesses the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures.

本年度回望——最少每一年开展一次的一种点评主题活动，即对每个药品的产品质量标准开展评定以决策是不是必须对药品技术规范或生产加工或管理程序进行变更。

2. CAPA– Corrective and preventive action: A systematic approach that includes actions needed to correct (“correction”), prevent recurrence (“corrective action”), and eliminate the cause of potential nonconforming product and other quality problems (preventive action) (21CFR 820.100).

CAPA——Corrective and prevention action，改正和防范措施，一种系统软件方式，包含必须纠正的个人行为（改正）、防止再次出现（改正个人行为）、清除潜在性的非一致性商品和其他产品质量问题造成的缘故（防止个人行为）（21 CFR 800.100）。

3. Continual Improvement – Ongoing activities to evaluate and positively change products, processes, and the quality system to increase effectiveness.

持续改善——持续发展趋势个人行为，以提升 法律效力为目地，对商品、加工工艺和品质系统软件开展评定和积极主动变动。

4. Correction– Repair, rework, or adjustment relating to the disposition of an existing discrepancy.

改正——对早已存有的误差开展挽救、返修或调节。

5. Corrective Action – Action taken to eliminate the causes of an existing discrepancy or other undesirable situation to prevent recurrence.

纠偏装置对策——为清除现有误差或其他不符合规定的状况、防止难题的再次出现所采用的行動。

6. Customer– A person or organization (internal or external) that receives a product or service anywhere along the product’s life cycle.

顾客——在商品全部生命期的一切环节，接到商品或服务项目的本人或机构（內部或外界的）。

7. Discrepancy– Datum or result outside of the expected range; an unfulfilled requirement; may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend.

误差——在预期成果范畴外的数据信息或結果；沒有做到的规定；也称之为非一致性、缺点、偏移、超标准或超过发展趋势。

8. Harm– Damage to health, including the damage that can occur from the loss of product quality or availability.

伤害——危害身心健康，包含因产品品质或实效性缺少造成的危害。

9. Non-conformity– A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements.

非一致性——特点、商品技术规范、加工工艺主要参数、纪录或程序流程上的缺点，使产品品质不能接纳、不确定性或不符特殊规定。

10. Preventive Action– Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence.

防范措施——为清除潜在性误差或其他不符合规定的状况、防止该类难题的再次出现所采用的对策。

11. Product/Service– The intended results of activities or processes; products/services can be tangible or intangible.

商品/服务项目——行動或加工工艺的预估内結果，商品/服务项目能够是有形化或无形中的。

12. Quality – A measure of a product’s or service’s ability to satisfy the customer’s stated or implied needs.

品质——对商品或服务能力是不是考虑顾客要求或默认设置的要求的一种考量方法。

13. Quality Assurance– Proactive and retrospective activities that provide confidence that requirements are fulfilled.

品质保证——展望或描述性研究的主题活动，以出示符合规定的自信心。

14. Quality Control – The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible.

质量管理——在商品或服务项目加工过程中采用的流程，以保证 商品/服务项目符合规定并可以反复。

15. Quality Management – Accountability for the successful implementation of the quality system。

质量控制——取得成功落实品质系统软件的义务。

16. Quality Objectives– Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy.

质量方针——可精确测量的特殊主题活动或全过程，以合乎品质现行政策所定义的目地和方位。

17. Quality Plan – The documented result of quality planning that is disseminated to all relevant levels of the organization.

质量计划——品质文档化的方案結果，规定传做到组织架构中的全部层级。

18. Quality Planning– A management activity that sets quality objectives and defines the operational and/or quality system processes and the resources needed to fulfill the objectives.

品质整体规划——一项管理方法主题活动，设置质量方针，并详尽要求做到该总体目标所必须的实际操作和/或品质系统软件步骤及其資源。

19. Quality Policy– A statement of intentions and direction issued by the highest level of the organization related to satisfying customer needs. It is similar to a strategic direction that communicates quality expectations that the organization is striving to achieve.

品质现行政策——机构顶层所公布的与考虑顾客要求有关的目地和方位的申明，它与机构的发展战略方位（要勤奋得到 的品质期待）相近。

20. Quality System– Formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement.

品质系统软件——宣布的商业服务实践活动，它详尽要求了管理人员在组织架构、加工工艺、程序流程和資源中的岗位职责，以执行商品/服务项目、考虑顾客及其开展持续改善。

21. Quality Unit– A group organized within an organization to promote quality in general practice.

重量单位——在平时实践活动中为保证质量，在机构內部创立的一个团队。

22. Risk– The combination of the probability of occurrence of harm and the severity of that harm.

风险性——伤害产生的概率和比较严重度的组成。

23. Risk Assessment– A systematic process for organizing information to support a risk decision that is made within a risk management process. The process consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.

风险评价——为了更好地支撑点风险性分辨，在风险性管理流程内所开展的一种针对性机构信息内容的步骤。该方式由伤害的确定、剖析和点评与伤害有关的风险性几一部分构成。

24. Risk Management – The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.

风险管控——质量控制现行政策、程序流程和实践活动实际操作的针对性应用，每日任务是对风险性开展评定、操纵、沟通交流和回望。

25. Senior Management– Top management officials in a firm who have the authority and responsibility to mobilize resources.

高层住宅管理方法——公司内的高級管理者，具备鼓励資源的受权和岗位职责。

26. Stakeholder– An individual or organization having an ownership or interest in the delivery, results, and metrics of the quality system framework or business process improvements.

相关者——个人或机构，在对品质系统软件架构内或商业化的加工工艺改善中的出让、結果、指标值，有着相对支配权和权益。比如，公司股东等。

27. Verification – Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor).

确定——确认，根据出示客观性直接证据对要求规定已获得考虑的评定。

28. Validation – Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. (Reference: The ASQ Auditing Handbook, 3rd edition, ASQ Quality Audit Division, J.P. Russell, Editor).

认证——确认，根据出示客观性直接证据对特殊的预估应用或运用规定已获得考虑的评定。

来源于：Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations，药闻药事 梳理编写